Tag Archives: Death

Highly effective vaccine, new warning signs, disrupted heart rhythm

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Pfizer vaccine appears highly effective

An experimental COVID-19 vaccine from Pfizer Inc and BioNTech SA appears to be more than 90% effective, based on data analyzed midway through a gold-standard clinical trial, the companies announced on Monday. The trial has enrolled 43,538 participants so far, including many from racially and ethnically diverse backgrounds. Pfizer said researchers had analyzed 94 confirmed cases of COVID-19 in trial participants and found the vast majority of the infections were in volunteers in the placebo group. The trial is expected to continue until 164 confirmed cases of COVID-19 are available for analysis. BioNTech’s co-founder and chief executive said he was optimistic that the protective effect of the experimental COVID-19 vaccine would last for at least a year.

New study adds to COVID-19 symptom list

Fever, coughing, and shortness of breath are known symptoms of COVID-19, but other warning signs can include weakness, poor blood sugar control and gastrointestinal complaints, according to a new study published on Saturday in the American Journal of Emergency Medicine. Researchers analyzed nearly 12,000 visits by adult patients to emergency departments at five New York City hospitals. They found COVID-19 in 57.5% of patients who went to the hospital because of weakness, falls, or altered mental status, in 55.5% of those who came in because their blood sugar was out of control, and in 51.4% of patients whose chief complaint was a gastrointestinal problem. Patients over the age of 65 tended to have more atypical complaints such as diarrhea, fatigue and weakness. Patients with dehydration, altered mental status, falls and high blood sugar were at higher risk for death in the study. The new findings can help hospitals provide better care and are “also important for family members and people that work with the elderly to better identify possible warning signs of COVID-19 infection,” coauthor Dr. Christopher Clifford of the Icahn School of Medicine at Mount Sinai told Reuters.

COVID-19 can fuse heart cells, disrupt rhythm

COVID-19 can disrupt the heart’s electric system, according to a report undergoing peer review at a Nature Research journal. The heart pumps blood by sending electrical signals through its “conducting cells” to tell “muscle cells” to contract. Normally, each conducting cell activates the one next to it in a domino effect to ensure smooth contractions. An autopsy of a COVID-19 patient found the virus had infected her heart in an unusual patchy pattern, “with small islands of infected cells here and there,” Dr. Jay Schneider of the Mayo Clinic in Rochester, Minnesota told Reuters. Upon further study in the laboratory, his team realized the spike protein on the surface of the new coronavirus can create holes between neighboring cells, causing them to fuse together. So instead of orderly electrical signal transmission and a steady heart rhythm, the signals flow like “a tsunami tidal wave” through the fused cells.

(Reporting by Nancy Lapid; Editing by Tiffany Wu)

New U.S. COVID-19 cases up 34% last week, set fresh records

By Michael Erman and Julie Steenhuysen

(Reuters) – Pfizer Inc’s experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.

Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.

Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance of a regulatory decision as soon as December.

If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

“Today is a great day for science and humanity,” said Pfizer Chief Executive Albert Bourla.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he said.

Experts said they still wanted to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.

“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and face covering set to remain for the foreseeable future.

Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which is expected in the third week of November.

U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.

MARKETS SURGE

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil companies and travel companies soared. Shares in companies that have thrived during lockdowns, such as conferencing platform Zoom Video and online retailers, tumbled.

Pfizer shares jumped more than 11% to their highest since July last year, while BioNTech’s stock hit a record high.

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson up 4% and Moderna Inc, whose vaccine uses a similar technology as the Pfizer shot, up 8%. Britain’s AstraZeneca, however, fell 2%. Moderna is expected to report results from its large-scale trial later this month.

“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”

U.S. President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he tweeted.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

The World Health Organization said the results were very positive, but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.

‘NEAR ECSTATIC’

“I’m near ecstatic,” Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. “This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”

Between 55% and 65% of the population will need to be vaccinated to break the dynamic of the spread of COVID-19, said Germany’s health minister Jens Spahn, adding that he did not expect a shot to be available before the first quarter of 2021.

The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.

The companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration’s Operation Warp Speed vaccine program.

The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.

Pfizer said the interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo.

Pfizer did not break down how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.

The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.

Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.

MORE DATA NEEDED

To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.

Pfizer said its data would be peer reviewed once it has results from the entire trial.

“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany.

Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million cases since the new coronavirus first emerged late last year in China.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.

(Reporting by Michael Erman and Julie Steenhuysen; Additional reporting by Michele Gershberg in New York, Ludwig Burger and Patricia Weiss in Frankfurt and Kate Kelland in London; Editing by Bill Berkrot, Caroline Humer, Edwina Gibbs and David Clarke)

Utah governor declares new state of emergency as coronavirus spreads

(Reuters) – The governor of the U.S. state of Utah, Gary Herbert, declared late on Sunday a new state of emergency to address hospital overcrowding in response to weeks of stress on its hospital networks due to a surge of novel coronavirus cases.

“Due to the alarming rate of COVID infections within our state, tonight I issued a new state of emergency with several critical changes to our response”, Herbert said on Twitter.

“These changes are not shutting down our economy, but are absolutely necessary to save lives and hospital capacity,” he said.

The governor said the entire state was being placed under a mask mandate until further notice and casual social gatherings were being limited to household-only for the next two weeks.

All extracurricular activities were being put on hold, he said.

The total number of coronavirus infections in the United States rose past 10 million late on Sunday, according to a Reuters tally.

Utah has had 132,621 total confirmed cases and 659 deaths from COVID-19 since the pandemic began.

(Reporting by Kanishka Singh in Bengaluru; Editing by Robert Birsel)

Guatemala Mayan villagers tell of harrowing escape from deadly landslide

By Sofia Menchu

CHICUZ, Guatemala (Reuters) – Matilde Ical Chen was toasting tortillas over a wood fire for the midday meal when the landslide ripped through the Guatemalan Mayan indigenous village of Queja, burying her mother, sisters and grandparents in a torrent of liquid earth and rock.

Ical Chen, 49, grabbed her husband and six small children and ran, barely surviving a fall into a ravine, she told Reuters in Chicuz, a hamlet three hours on foot from Queja, where she and hundreds of other survivors are now sheltered in a primary school after Thursday’s disaster.

“My mother was buried, along with my sisters, their husbands, the whole family, even the grandparents,” Ical Chen said though an interpreter, counting approximately 30 family members who did not escape the mud that rescuers say is up to 50 feet (15 meters) deep.

“We have food here, but I can’t eat for the worry,” she said, clutching a scarf as tears ran down her cheeks.

A deluge linked to storm Eta killed dozens and caused devastation from Panama to Mexico last week. But perhaps nowhere was harder hit than Guatemala, where poor Mayan villages precariously perched on lush mountainsides are susceptible to landslides.

Rescuers say they may never know how many people were buried in the mud in Queja, about 200 km (125 miles) from Guatemala City. The government has estimated up to 150 lives lost.

But braving loose ground and new landslides that made rescue work perilous, survivors returned on Sunday desperately looking for relatives and scant belongings – clothes, a little food, their livestock.

With the first break from days of relentless rain allowing more access, helicopters buzzed in and out of the village and surrounding hamlets, bringing supplies and rescue workers who recovered at least six bodies, even as new landslides endangered more lives.

At least two people were killed when a light aircraft carrying humanitarian aid for the disaster area crashed in Guatemala City, while another helicopter was forced to make an emergency landing.

Rolando Cal was among the survivors who made the treacherous trek back to Queja, a Poqomchi’ Mayan settlement of about 1,300 people, searching for any of his 23 relatives lost in the mud when the mountainside collapsed after days of rain.

“This is where my whole family and my home were destroyed,” Cal said, pointing to a pile of rubble where his house once stood, a vast gash of bare earth stark against the lush landscape and remaining houses beyond.

“I no longer have a place to live,” said Cal, who walked into Queja on Sunday from neighboring Santa Elena, where he has found shelter. “Without food, without money. I’m miserable.”

When a helicopter carrying supplies organized by a retired general, Francisco Mus, arrived in Chicuz, survivors huddled in the schoolyard ran out, desperate for possible news of loved ones left behind. Among some 450 people sheltered at the school, many were saved by Chicuz residents who risked their own lives to clamber into gullies and pull stranded families up with ropes, village official Raul Gualin said.

Bedraggled, and with only the clothes on her back, Ical Chen said she was grateful to the village for taking her in. She too thinks she, her husband and children will not return to Queja now, or maybe ever.

“We will try to find refuge in another place, and not go back there,” she said. “I lost my whole family.”

(Additional reporting Luis Echeverria in Queja and by Enrique Garcia in Guatemala City; Writing by Anthony Esposito; Editing by Frank Jack Daniel and Gerry Doyle)

U.S. CDC reports 234,264 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Friday reported 9,581,770 cases of the new coronavirus, an increase of 117,988 cases from its previous count, and said that the number of deaths had risen by 1,135 to 234,264.

The CDC reported its tally of cases of the respiratory illness known as COVID-19, caused by a new coronavirus, as of 4 pm ET on Nov. 5 versus its previous report a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Dania Nadeem in Bengaluru; Editing by Aditya Soni)

Britain prepares for COVID-19 vaccine as Oxford forecasts result this year

By Alistair Smout and Guy Faulconbridge

LONDON (Reuters) – Late-stage trial results of a potential COVID-19 vaccine being developed by the University of Oxford and AstraZeneca could be presented this year as the British government prepares for a possible vaccination rollout in late December or early 2021.

A vaccine is seen as a game-changer in the battle against the coronavirus, which has killed more than 1.2 million people worldwide, shuttered swathes of the global economy and turned normal life upside down for billions of people.

There are more than 200 candidates under development and the vaccine being developed by Oxford and licensed to British drugmaker AstraZeneca is seen as a front-runner.

“I’m optimistic that we could reach that point before the end of this year,” Oxford Vaccine Trial Chief Investigator Andrew Pollard said of the chances of presenting trial results.

Pollard told British lawmakers that establishing whether or not the vaccine worked would likely come this year, after which the data would have to be carefully reviewed by regulators and then a political decision made on who should receive it.

“Our bit – we are getting closer to but we are not there yet,” Pollard, director of the Oxford Vaccine Group, said.

Asked if he expected the vaccine would start to be deployed before Christmas, he said: “There is a small chance of that being possible but I just don’t know.”

The National Health Service (NHS) in England is preparing to start distributing possible COVID-19 vaccines before Christmas in case one is ready by the end of the year.

The Oxford/AstraZeneca vaccine is expected to be one of the first from big pharma to be submitted for regulatory approval, along with Pfizer and BioNTech’s candidate.

“If I put on my rose-tinted specs, I would hope that we will see positive interim data from both Oxford and from Pfizer/BioNTech in early December and if we get that then I think we have got the possibility of deploying by the year end,” Kate Bingham, the chair of the UK Vaccine Taskforce, told lawmakers.

Prime Minister Boris Johnson said there was the prospect of a vaccine in the first quarter of 2021. AstraZeneca is presenting its third quarter financial results on Thursday.

‘GAME CHANGER’

Work on the Oxford viral vector vaccine, called AZD1222 or ChAdOx1 nCoV-19, began in January. It is made from a weakened version of a common cold virus that causes infections in chimpanzees.

The chimpanzee cold virus has been genetically changed to include the genetic sequence of the so-called spike protein which the coronavirus uses to gain entry to human cells. The hope is that the human body will then attack the novel coronavirus if it sees it again.

If Oxford’s vaccine works, it could eventually allow the world to return to some measure of normality.

Asked what success looked like, Pollard said: “Good is having vaccines that have significant efficacy – so whether, I mean, that is 50, 60, 70, 80 percent, whatever the figure is – is an enormous achievement.

“It’s a complete game changer and a success if we meet those efficacy end points,” he said, adding it would relieve pressure on the health system.

But Pollard and Bingham agreed that the world would not return to normal immediately. Asked about the chances of a vaccine that would wipe out the coronavirus next year, Bingham said the prospects were “very slim.”

“(But the chances) to get a vaccine that has an effect of both reducing illness, and reducing mortality (are) very high,” Bingham said, adding she was more than 50% confident there would be such a vaccine by early summer.

(Reporting by Alistair Smout and Guy Faulconbridge; Editing by Nick Macfie and Alexander Smith)

U.S. CDC reports 230,893 deaths from coronavirus

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) on Tuesday reported 9,268,818 cases of the novel coronavirus, an increase of 86,190 cases from its previous count, and said that the number of deaths had risen by 510 to 230,893.

The CDC reported its tally of cases of the respiratory illness known as COVID-19 as of 4 p.m. ET on Nov. 2, compared with its previous report released a day earlier.

The CDC figures do not necessarily reflect cases reported by individual states.

(Reporting by Mrinalika Roy in Bengaluru)

As Americans head to the polls, COVID-19’s long shadow looms

By Nick Brown and Ernest Scheyder

(Reuters) – For many Americans, this is the coronavirus election.

The pandemic has killed about 230,000 people in the country and destroyed millions of jobs, defining the last year of Donald Trump’s presidency and becoming a rallying cry for his Democratic opponent, Joe Biden.

Here are stories from a cross-section of Americans – voters and officials – for whom COVID-19 is the driving force in Tuesday’s election. Their stories underscore why the disease casts a long shadow over the 2020 U.S. presidential election.

SONIKA RANDEV, 36, NEW YORK, NEW YORK

Dr. Sonika Randev has had a dark year. In March, when she was a medical resident at New York’s Metropolitan Hospital, Randev contracted COVID-19, spending three weeks battling fever, brain fog, body aches, a loss of taste and smell and what she termed a “bone-chilling cold.”

Afterward, figuring she was immune to the coronavirus, Randev volunteered to care for the hospital’s sickest COVID patients, watching many die.

“My unit became an end-of-life unit,” she said. “We were basically waiting for patients to pass away or go to hospice.”

Melancholy quickly set in.

New York’s nightly ritual – in which people clapped and cheered for healthcare workers from their windows – stopped buoying Randev’s spirits. She found herself shutting her windows to the sound, which only reminded her of “the sea of misery” the city had become. When friends and colleagues took to drowning their sorrows, Randev found drinking only made her feel worse, so she stopped.

She felt powerless.

Now, as she gets back on her feet, she said she is trying to take some of that power back – by voting for Democratic candidate Joe Biden.

“Being able to go to the polls and finally exert some control just by casting a vote, I think that’s something powerful,” Randev said.

Recalling how doctors were forced to reuse the same masks and gowns for days, Randev said Trump should have done more to boost supply of protective gear. She also feels Trump unfairly left state governments to fight the pandemic on their own, then “turned around and criticized” those who imposed strict lockdowns.

In a statement to Reuters in October, a Trump campaign spokeswoman said the president has faced the pandemic “head on,” citing his restrictions on travel from China, adding that “he will not stop until we’ve beaten the coronavirus.”

But Randev does not believe Trump would do any better in a second term. “He is who he is,” she said. “He’s never going to change.”

CHRIS HOLLINS, 34, HOUSTON, TEXAS

It has been less than six months since Chris Hollins was thrust into the job of running elections in Harris County, Texas – the largest county in a historically conservative state that Biden has a chance of flipping.

Already, the new county clerk has battled Texas’ Republican governor and attorney general on voting rights access, underscoring the bitter battle for votes in the second-largest U.S. state.

Hollins launched drive-through voting and kept some early-voting locations open 24/7, largely for the convenience of the county’s large numbers of medical and oil industry workers, who often work odd hours.

A Republican state representative sued Hollins for the county’s use of drive-through voting in both the Texas Supreme Court, which rejected the suit on Sunday, and in federal court, where a judge on Monday ruled against it as well.

Hollins opposed the governor’s order limiting counties to one drop-off location for absentee ballots.

As a public appointee, Hollins cannot publicly endorse a candidate, though he is a Democrat.

Prodded partly by the COVID-19 pandemic, county commissioners boosted the election budget seven fold from 2016 levels to $27.7 million. Hollins used that money to triple the county’s early-voting locations to 120.

Plastic coverings that Hollins’ office bought for voters’ fingers – the county uses touchscreen voting terminals – have gone viral on social media, with some playfully describing them as “finger condoms.”

Hollins said his job is “to make sure every voter in Harris County has an opportunity to cast their ballots and can do so safely.”

He and the county have been largely been successful: By Oct. 29, more county voters had cast early ballots than in the entire 2016 election.

GLORIA “LEE” SNOVER, 52, BETHLEHEM TOWNSHIP, PENNSYLVANIA

Her father died of it. Her mother spent eight days in the ICU; her husband, 17 days. Five others in her family contracted it, including herself. For Lee Snover, COVID-19 was more than a news story. It was a family crisis.

Still, Snover goes to the polls more determined than ever to reelect Trump. The chair of the Republican Committee of Northampton County, Pennsylvania – a crucial swing district Trump won in 2016 – said that despite widespread criticism of the president’s handling of the disease, it never occurred to her to blame him for the pandemic that ravaged her family’s health and hamstrung its construction business.

Snover hit emotional rock-bottom the day of her father’s funeral in April, when, battling her own mild COVID diagnosis, she was forced to stay home. The same day, her husband entered the hospital with worsening symptoms. Her mother would soon join. The virus would ensnare eight family members total.

COVID has infected 5,700 Northampton residents and killed 315, according to Pennsylvania Department of Health data. That is 103 deaths per 100,000 residents, well above the U.S. average.

Snover opposes economic shutdowns, equating them to letting the virus win, even though doctors have said social distancing is the best way to beat COVID. “We see life as you gotta survive, you gotta win. We’re not victims. When something hits us, we beat it back and win,” she said.

With Trump behind in opinion polls, Snover says her last vote as a party official carries special weight.

“All this about women’s rights, and ‘Women are so mighty,’ but I look at them on Facebook and all they talk about is fear,” she said. “Putting my finger on that machine button and casting that ballot — that’s a victory against COVID.”

GARY SIMS, 52, RALEIGH, North Carolina

COVID-19 has caused Gary Sims to lose sleep, weight and time with his daughters – and he hasn’t even had the disease.

As director of elections for Wake County, North Carolina, Sims must stage a vote in the most populous county of a crucial battleground state, in the midst of a public health nightmare. The stress is eating him alive, he said.

From online poll worker training to mailing out hundreds of thousands of absentee ballots, “everything has been unprecedented,” Sims said.

He has had to reconfigure his agency’s 76,000-square-foot headquarters so that it can process five times its usual haul of mail ballots while keeping workers much farther apart than normal.

He has seen his two grown daughters just once this year, even though they live close by – for their own protection, he said, since he can’t work from home and is more exposed to the virus.

No stranger to pressure, the U.S. military veteran saw combat in two foreign conflicts. He worries political tensions could lead to confrontation, or that poll workers – many of whom are first-timers this year – could grow overwhelmed by the added burdens of enforcing social distancing and contending with a high turnout of partisan poll observers.

Sims’ blood pressure has spiked. Struggling to stomach solid foods, he’s subsisted mostly on protein shakes. He has lost 40 pounds (18 kg) in two months. “Did I need to lose the weight?” he said. “Yeah. Did I plan to lose it like that? No.”

As an official in charge of fair elections, Sims cannot reveal his own voting plans, but said he is an independent who votes with his daughters in mind.

“They’re getting their future started,” he said. “So my vote is for what’s best for them.”

ISRAEL SUAREZ, 76, FORT MYERS, FLORIDA

Israel Suarez nearly died after he contracted COVID-19 in August, but he did not let that stop him from voting.

Suarez spent 10 days in a Florida hospital and said he was convinced he was going to die. After the ordeal, the lifelong Republican and native of Puerto Rico voted early in October, an act he called a civic duty.

“The coronavirus shouldn’t stop anyone from exercising their moral and social responsibility to vote,” said Suarez, who founded the Nations Association Charities in Fort Myers, Florida, a nonprofit that runs youth groups and other community outreach programs.

Until now, Suarez has affiliated with Republican causes and politics. But this year, he’s supporting Biden.

“I’m so fed up with this man, Mr. Trump, because I almost died,” Suarez said. “I almost lost my life because of him.”

Suarez said Trump has divided and confused the country by failing to lead it successfully through the pandemic.

Suarez added that he persuaded his wife and daughter to vote for Biden, too. Biden “is a moral man,” Suarez said, “no matter what people think of him.”

(Reporting by Nick Brown and Ernest Scheyder; Editing by Ross Colvin and Cynthia Osterman)

Pfizer says earliest COVID-19 vaccine application to U.S. regulators would be after election

By Manas Mishra and Michael Erman

(Reuters) – Pfizer Inc said on Friday it may file for U.S. authorization of the COVID-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the U.S. election as President Donald Trump has promised.

Pfizer said that it may say if the vaccine is effective as soon as this month based on its 40,000 person clinical trial but that it also needs safety data that will not be available until November at the earliest.

The Pfizer news, published in a letter from its chief executive on its website, lifted the U.S. stock market and the company’s shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development.

“So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November,” Pfizer Chief Executive Albert Bourla said.

Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall.

The president’s rush to a vaccine has also raised concerns that the U.S. Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine.

U.S. health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalized a requirement that the vaccine makers collect two months of safety data on one-half of trial participants.

Pfizer’s comments on its time line raise the possibility of U.S. authorization of a coronavirus vaccine this year, a key step in controlling the COVID-19 pandemic, which has killed more than a million people and ravaged the global economy.

Moderna could also apply for an emergency use authorization (EUA) this year. It has said that it may have interim data on its 30,000 person trial as soon as November.

Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. AstraZeneca’s U.S. trial has been on hold since September.

After the FDA announced the two-month requirement on Oct. 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov. 3., Trump called the move a ‘political hit job.’

In addition to safety and efficacy, the FDA will also examine Pfizer’s manufacturing operations for the vaccine.

Bourla said the filing depended on several other factors, including initial data on effectiveness that may or may not be available by late October.

He said the company plans to share efficacy data with the public as soon as practical. (https://bit.ly/31bWdpP)

A BioNTech spokeswoman confirmed the time frame for the possible EUA application to the FDA.

Pfizer’s shares rose 2.1% in premarket trading, while BioNTech’s U.S-listed shares were up 4% before the opening bell. Moderna was unchanged and U.S. futures were higher.

(Reporting by Manas Mishra, Manojna Maddipatla in Bengaluru and Michael Erman in New Jersey, Patricia Weiss in Frankfurt; writing by Caroline Humer in New York; Editing by Patrick Graham, Saumyadeb Chakrabarty and Steve Orlofsky)

U.S. coronavirus cases surpass eight million as infections spike nationwide

By Anurag Maan and Shaina Ahluwalia

(Reuters) – U.S. cases of the novel coronavirus crossed 8 million on Thursday, rising by 1 million in less than a month, as another surge in cases hits the nation at the onset of cooler weather.

Since the pandemic started, over 217,000 people have died in the United States.

The United States reported 60,000 new infections on Wednesday, the highest since Aug. 14, with rising cases in every region, especially the Midwest.

Health experts have long warned that colder temperatures driving people inside could promote the spread of the virus. They have not pinpointed the reason for the rise but point to fatigue with COVID-19 precautions and students returning to schools and colleges.

According to a Reuters analysis, 25 states have so far set records for increases in new cases in October.

All Midwest and Northeast states have reported more cases in the past four weeks than in the prior four weeks, with the number of new cases doubling in states like Wisconsin, South Dakota and New Hampshire.

In the Midwest, daily new cases hit a record on Wednesday with over 22,000 new infections. The positive test rate tops 30% in South Dakota and 20% in Idaho and Wisconsin.

Ten states on Thursday reported record increases in new cases, including Wisconsin with 4,000 new cases. “Our numbers are high and they’re growing rapidly,” state Health Secretary-Designate Andrea Palm told a news conference.

“We have now surpassed 1,000 COVID-19 patients who are in the hospital. In some regions of our state, our ICU beds are 90% or more full. Over the course of the past six weeks, our average daily deaths have more than tripled,” Palm added.

California remains the state with the most total cases followed by Texas, Florida, New York and Georgia. Those five states account for over 40% of all reported COVID-19 cases in the nation.

With both cases and positive test rates rising in recent weeks, New York City has closed businesses and schools in neighborhood hot spots despite protests from a small contingent of Orthodox Jews.

In addition to rising cases, hospitals in several states are straining to handle an influx of patients.

In the Midwest, COVID-19 hospitalizations hit a record high for a tenth day in a row on Wednesday. Nationally, the United States reported nearly 37,000 hospitalizations, the highest since Aug. 28.

Wisconsin, which reported record hospitalization on Wednesday, has opened a field hospital outside of Milwaukee to handle COVID-19 patients.

(Reporting by Anurag Maan, Shaina Ahluwalia and Chaithra J in Bengaluru; Editing by Lisa Shumaker)